Evaluation of a Standardized Tacrolimus Therapeutic Drug Monitoring Protocol in Stable Kidney Transplant Recipients.

Introduction: Transplant nurse coordinators have assisted in accurately adjusting tacrolimus doses under a collaborative practice agreement for kidney transplant recipients in the early post-operative period. This study evaluated the efficiency of a standardized tacrolimus therapeutic drug monitoring (TDM) protocol in stable outpatient recipients. Design: We conducted a single-center, retrospective study of adult patients who received a kidney transplant at least 3 years ago and were taking immediate-release tacrolimus. Before September 2019, transplant coordinators consulted transplant providers for management of all tacrolimus trough levels (Pre-Arm). Under the standardized protocol, coordinators directly responded to out-of-range tacrolimus trough levels (Post-Arm). The primary outcome was the time to intervention for out-of-range levels. Secondary outcomes included adverse events, time in therapeutic range, coefficient of variation (CV), and protocol compliance. Results: Of 1712 levels (from 174 patients), 259 levels (15.1%) were out-of-range. The overall time to intervention was 13.2 hours shorter (95% CI: -26.4 to -0.1 hours; P = 0.048) in the Post-Arm. There was no rejection, graft loss, or death during the study period. The time in therapeutic range was 89.3% (17.6%) vs 89% (19.4%; P = 0.816) and CV was 19.7% (15.8%) vs 18.4 (10.7%; P = 0.358) in the Pre-Arm and Post-Arm, respectively. Within the Post-Arm, the protocol required coordinators to independently intervene on 96 out-of-range levels (65.8%), which were accurately addressed 57.5% of the time. Conclusion: Implementation of a standardized TDM protocol improved efficiency without compromising major clinical outcomes or intrapatient variability (IPV) of tacrolimus levels for stable kidney recipients in the outpatient setting.

Oropharyngeal candidiasis outcomes in renal transplant recipients receiving nystatin versus no antifungal prophylaxis.

OBJECTIVE: To compare the incidence of oropharyngeal candidiasis (OC), or thrush, in renal transplant recipients receiving nystatin versus no antifungal prophylaxis. METHODS: This was a single-center, retrospective, non-inferiority study of adult renal transplant recipients (RTRs) who received nystatin for 30 days for OC prophylaxis (nystatin group) or no antifungal prophylaxis therapy (No PPX group). The primary outcome was the incidence of OC within 3 months post-transplant. Secondary outcomes included time to OC occurrence and severity of OC. The pre-specified non-inferiority margin was 10%. RESULTS: The incidence of OC within 3 months post-transplant among 257 RTRs was 7.8% (10/128) in the No PPX group and 4.7% (6/129) RTRs in the nystatin group, a risk difference of 3.2% (95% CI, -2.7% to 9.1%, non-inferiority P = .04). The median time to OC was 7.5 days (IQR 6.3-34.3 days) in the nystatin group and 9.5 days (IQR 5.3-30.5 days) in the No PPX group (P = .64). Esophageal candidiasis was observed in 10% (1/10) of RTRs with OC in the No PPX group compared to 16.7% (1/6) RTRs in the nystatin group (P = 1.00). All RTRs with OC achieved symptom resolution with fluconazole and/or nystatin. Two patients in the No PPX group required readmission for decreased oral intake, and OC was diagnosed and treated during their hospital day. CONCLUSIONS: In this retrospective study of adult RTRs, the absence of antifungal prophylaxis demonstrated non-inferiority to 30-day nystatin prophylaxis at reducing the incidence of OC within 3 months of transplant. OC prophylaxis may not be warranted after renal transplant.